Respiration Stimulation

ABSTRACT

An automated respiration stimulation apparatus comprising a detector configured to measure a respiratory cycle of a user and a stimulator configured to automatically apply a stimulation to the user&#39;s acoustic nerve to interrupt a disturbance in the respiratory cycle of the user in response to the detection of the disturbance as indicated by the respiratory cycle measurements of the detector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/804,706, entitled “RESPIRATION STIMULATION APPARATUS,” filed Jun. 14,2006, the disclosure of which is hereby incorporated herein byreference.

This application is also related to commonly-assigned U.S. applicationSer. No. 11/424,011, entitled “RESPIRATION STIMULATION APPARATUS,” filedJun. 14, 2006, the disclosure of which is hereby incorporated herein byreference.

BACKGROUND

Embodiments of the present disclosure generally relate to respiration.More specifically, the present disclosure relates to apparatus andmethods for stimulating respiration during sleep.

A clinical pathologic entity called Sleep Apnea Syndrome (SAS) affectsmany individuals around the world. SAS is currently generallycharacterized by repetitive stops of respiration. SAS may cause severedisturbances of sleep, and may have deleterious effects on mentalactivities, such as intellectual performance, memory, and behavior.Further, SAS is known as one of the causes of cardiovascular diseases,increased blood pressure (hypertension), stroke, heart arrhythmia, andconduction disturbances, which may lead to fatal cardiac arrest. SAS isespecially dangerous in patents having chronic lung and heart diseases.

A common means of physiologic protection against SAS is usually arousalfrom sleep and the restoration of normal breathing as a result oftemporary normalization of the cortical neural control of respiration.However, as expected, these repetitive arousals result in fragmented anddisturbed sleep.

Current treatments of SAS have been limited to mechanical stenting ofthe airway via CPAP (continuous positive airway pressure) devices andoral appliances, as well as surgical procedures aimed at removing,reducing, repositioning, or stiffening tissue in the upper airway. CPAPand oral devices currently have only a 50%-60% compliance rate becauseof patients' feelings of claustrophobia, nasal stuffiness, andinconvenience related to these devices' awkward and cumbersomeequipment. Moreover, surgical treatments are usually very painful,require the use of general anesthesia, and can have severecomplications. In the medical literature, surgical interventions are, atbest, about 60-70% effective at curing SAS.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is best understood from the following detaileddescription when read with the accompanying figures. It is emphasizedthat, in accordance with the standard practice in the industry, variousfeatures are not drawn to scale. In fact, the dimensions of the variousfeatures may be arbitrarily increased or reduced for clarity ofdiscussion.

FIG. 1 is a block diagram of a device for acoustic stimulation ofrespiration in accordance with one or more aspects of the presentdisclosure.

FIG. 2 is a circuit diagram of a device in accordance with one or moreaspects of the present disclosure.

FIG. 3 is a perspective view of a nasal device disposed on a user inaccordance with one or more aspects of the present disclosure.

FIG. 4 is a schematic view of a stimulator device disposed in an ear ofa user in accordance with one or more aspects of the present disclosure.

FIG. 5 is a schematic view of an ear device disposed in an ear of a userin accordance with one or more aspects of the present disclosure.

FIG. 6 is a schematic view of the device shown in FIG. 5.

DETAILED DESCRIPTION

It is to be understood that the following disclosure provides manydifferent embodiments, or examples, for implementing different featuresof various embodiments. Specific examples of components and arrangementsare described below to simplify the present disclosure. These are, ofcourse, merely examples and are not intended to be limiting. Inaddition, the present disclosure may repeat reference numerals and/orletters in the various examples. This repetition is for the purpose ofsimplicity and clarity and does not in itself dictate a relationshipbetween the various embodiments and/or configurations discussed.Moreover, the formation of a first feature over or on a second featurein the description that follows may include embodiments in which thefirst and second features are formed in direct contact, and may alsoinclude embodiments in which additional features may be formedinterposing the first and second features, such that the first andsecond features may not be in direct contact.

Apparatus within the scope of the present disclosure may be powered byany suitable power source, such as a battery, docking station, power inthe wall, multiple batteries, and/or others. However, although merelyfor the sake clarity, such power source is not depicted in the figures.Nonetheless, those skilled in the pertinent art will recognize that anypower scheme is within the scope of the present disclosure.

FIG. 1 is a block diagram of an automated apparatus 100 for acousticstimulation of respiration in accordance with one or more aspects of thepresent disclosure. As illustrated in FIG. 1, the apparatus 100 includesa sensor or detector 105. The detector 105 is configured to measureparameters related to the respiratory cycle of the user, and thenprovide an output signal indicative of the user's respiratory cycle.

For example, the detector 105 may be or comprise a thermistor and/orother air-flow detector, which is affixable in or adjacent to the noseand/or mouth of the user. Alternatively, or additionally, the detector105 may be or comprise a rib-cage movement detector (e.g., forinductance plethysmography) configured to be affixed across the torso ofthe user and to provide an output signal responsive to thoracoabdominalmotion and expansion and/or contraction of the rib-cage duringbreathing. Alternatively, or additionally, the detector 105 may be orcomprise an ear plug detector configured to measure the respiratorycycle of the user via sounds and/or vibrations transmitted to the ear ofthe user. Alternatively, or additionally, the detector 105 may beconfigured to measure the percentage of oxygen or other parameters inthe blood stream of the user. Alternately, or additionally, the detector105 may be or comprise a wearable detector such as a hand or wristdetector that is configured to measure respiration by measurement ofarterial tone. In an exemplary embodiment, one or more different kindsof detectors may be affixed to or positioned proximate one or morevarious parts of the user's body. It should be understood, however, thatthe detector 105 may be or comprise any type of mechanism or combinationable to measure parameters of respiration or the respiratory cycle of auser and provide an electrical and/or other output signal indicative ofthe respiration or the respiratory cycle of the user, without departingfrom the principles of the present disclosure.

One or more components of the apparatus 100, whether individually or incombination, are configured to apply a stimulus to the user in responseto detection by the detector 105 of apnea or other respirationdisturbance. Such component(s) may be or include the detector 105, astimulator 140, and/or another one or more components of the apparatus100.

In an exemplary embodiment, the apparatus 100 may comprise a controllerdevice configured to control the inducement of such stimulation inresponse to the detection of respiration disturbance. For example, sucha controller may comprise the combination of components shown in theexemplary embodiment depicted in FIG. 1. Alternatively, the controlfunction may be performed by the detector 105 and/or the stimulator 140,whether individually or in combination, such that the apparatus 100 maynot include each or all of the discrete components depicted in theexemplary embodiment of FIG. 1. Nonetheless, although merely for thesake of clarity and example, these other components of the exemplaryembodiment of the apparatus 100 shown in FIG. 1 are described below,although it is understood that the function of one or more of thecomponents may be performed by the detector 105, the stimulator 140,and/or components of the apparatus 100 other than as described below.

The output signal produced by the detector 105 is sent to a controldevice 102, which is schematically depicted in FIG. 1 by the dashedlines. As described above, the control device 102, or whichevercomponent(s) is configured to perform the function of the control device102, is configured to receive a signal from the detector 105, analyzethe signal, and then send another signal to the stimulator 140. In theexemplary embodiment shown in FIG. 1, the control device 102 comprisesan amplifier 110, a wave shaping circuit 115, a pause unit 120, amonitor 125, a critical pause control circuit 130, and a signalgenerator 135. It should be understood, however, that the control device102 is not limited to the embodiment depicted in FIG. 1. That is, thecontrol device 102 may be any device or combination that is configuredto receive a signal from the detector 105, analyze the signal, and thensend another signal to the stimulator 140, without departing fromprinciples of the present disclosure. For example, in an exemplaryembodiment, the control device 102 and/or any other components in theapparatus 100 could be implemented as an integrated circuit and/or acentral processing unit (CPU), and may utilize further components suchas memory to enhance their function.

In the exemplary embodiment shown in FIG. 1, the output signal producedby the detector 105 is amplified by the amplifier 110 and then sent tothe wave shaping circuit 115. The wave shaping circuit 115 is configuredto change the amplified signal into a shaped signal, such as a squarewave, which is indicative of the user's respiratory cycle. Thereafter,the shaped signal is sent to the pause unit 120 for monitoring. Thepause unit 120 is configured to measure the duration between adjacentoutput signals generated by the wave shaping circuit 115 or, conversely,the duration of signal pause between consecutive output signals orpulses. During normal breathing, a visual and/or audible signal may beactivated by the monitor 125. In this exemplary embodiment, the systemis configured to detect an apnea, or an error, abnormality, malfunctionor other disturbance in respiration, or a certain pattern inrespiration. For example, such event may be a cessation or pause ofrespiration which exceeds a predetermined period of time. Upon detectionof such event, the monitor 125 may be deactivated and/or caused to emita signal indicative thereof. The time period may be about 10 seconds,although other time periods are also within the scope of the presentdisclosure.

The pause unit 120 also receives signals of adjustable duration from thecritical pause control circuit 130. These signals are used by the pauseunit 120 in determining whether the duration between consecutive outputsignals generated by the wave shaping circuit 115 have exceeded thepreset period of time. If the period of time has been exceeded, thepause unit 120 activates the signal generator 135, which operates thestimulator 140 to interrupt the apnea episode or other respiration cycledisturbance and restore normal breathing of the user, possibly withoutfully arousing the user.

For example, the stimulator 140 may be configured to apply stimuli orsend electrical, mechanical, and/or acoustic signals to one or morepoints of stimulation to restore normal breathing of the user withoutfully waking the user. The stimulation may also or alternatively be inthe form of vibration. The one or more points of stimulation may includean eardrum, tympanic membrane, acoustic nerve, and/or cerebral cortex ofthe user. In one embodiment, the acoustic stimulation may stimulate theacoustic nerve which, in turn, stimulates respiration. However, otherpoints of stimulation are also within the scope of the presentdisclosure. Moreover, the stimulator 140 may be adjusted manually orautomatically according to characteristics of the user, as describedbelow.

One or more of the functions of the previously described components maybe performed by a component other than as described above. Moreover, oneor more of the described components may or may not be included in theapparatus 100. In addition, the apparatus 100 may include componentsother than as described above or depicted in FIG. 1, includingcomponents which provide additional function or enhancements to theapparatus 100, such as a memory component. For example, a memorycomponent may be utilized in the apparatus 100 to log the time,duration, and/or frequency of each respiration parameter and/orstimulus. Consequently, the logged information may be downloaded and/oranalyzed or otherwise accessed, and may be used to report to thetreating physician or for other purposes. It should be understood thatthe apparatus 100 may also be implemented via conventional orfuture-developed devices, such as may include one or moremicroprocessors, and may utilize wireline and/or wireless operation.

The stimulation applied by the stimulator 140 may be or comprise asound, acoustic wave, or other signal (herein collectively referred toas a signal), or a sequence thereof. The frequency, decibel, spacing,shape and/or duration of each or all of the signals can vary, whetherindividually or collectively, and may be manually or automaticallyreconfigured based on, for example, physical or sleep characteristics ofthe user. The signal(s) may have one or more frequencies which fallwithin frequencies that are within the normal hearing range of the user,while other signals may fall within frequencies that are above or belowthe range for normal hearing. The signal examples and parameters listedabove (e.g., frequency, duration, decibel, shape) are not an exhaustivelist, and any additional parameters may be altered within the scope ofthe present disclosure.

The stimulation can further be configured to vary over time, and cancombined with other stimulation. For example, different acoustic wavesmay be delivered to each ear, a combination of sounds may be applied inone ear or both ears, and/or two or more sounds may be presented in asequence. Moreover, the stimulation may comprise one or more soundsignals combined with, for example, their respective harmonic ornon-harmonic frequencies in a subtractive and/or additive manner, suchas to generate a harmonic signal. Such sound or resultant harmonics ornon-harmonics can be within or beyond a human sound perception range,that is perceptible or imperceptible by the user, whether while in asleep cycle or when fully aroused. Such acoustic stimulation may also becombined with other, non acoustic stimulation, such as physical orvisual stimulation. In general, the specifics of the stimulation appliedby the stimulator 140 is not necessarily limited within the scope of thepresent disclosure. In contrast, at least according to one or moreaspects of the present disclosure, the stimulation applied by thestimulator 140 is configured such that respiratory cessation, whendetected, is interrupted, and possibly without fully arousing the userfrom the sleep cycle.

Moreover, in one exemplary embodiment, the stimulation applied by thestimulator 140 may be customized per the user. Such arrangement allowsthe stimulation to be adjusted per the individual needs of the user,such that the stimulation can be based on characteristics of eachindividual user. For example, the frequency, decibels, shape and/orduration of the stimulation signal(s) may be configured based oncharacteristics of each individual user.

The configuration of one or more aspects of the stimulation may bemanually performable by the user, the user's physician, and/or anotherperson. Alternatively, the configuration of one or more aspects of thestimulation may be automatically performed by one or more components ofthe apparatus 100. In either case, the apparatus 100 may be configurablein a manner that allows tuning and configuration over time.

Similarly, the input parameters may also be configurable. For example,sensitivity of the detector 105, predetermined parameters of respirationerror (such as length of respiration cessation), and/or other aspects ofthe detection of respiration error and/or triggering of the stimulationapplied by the stimulator 140 may be manually or automaticallyconfigurable.

In embodiments in which the input parameters or the stimulationparameters are configurable, whether manually by the user, physician orsleep lab staff or automatically by one or more components of theapparatus 100, the apparatus 100 may be configured in a manner whichallows these parameters to be set and/or titrated once or repeatedly,such as in a manner allowing tuning of the apparatus 100 by the user orprofessional personnel. Additionally, or alternatively, these parametersmay be set prior to delivery of the apparatus 100 to the user or user'sphysician, such as before the apparatus 100 leaves the factory at whichthe apparatus 100 is manufactured or assembled.

The apparatus 100 may be further configured to adjust and change overtime to maintain the effectiveness of the stimulation and possiblyprevent habituation. This can include changes in volume, combinationwith other sounds, and/or other changes in the input parameters and/orstimulation parameters. Such configuration may be performed manually orautomatically.

In one exemplary embodiment, the stimulation parameters may be manuallyor automatically configured such that the stimulation does not cause anysignificant changes in the patient and/or the patient's sleeparchitecture, except for the disturbance or interruption of the apnea orother respiration cessation. For example, the stimulation parameters maybe manually or automatically configured such that the user's sleep cycleis not significantly disturbed, as possibly indicated by EEG analysis.However, at least in one exemplary embodiment, micro-arousals as knownin the current literature may not constitute a significant arousal orawakening of the patient according to one or more aspects of the presentdisclosure.

Further, in an exemplary embodiment, the apparatus 100 may be configuredto automatically detect one or more characteristics of the user andsubsequently utilize the detected characteristics to titrate one or moreof the above-described stimulation parameters. The titration process maybe performed by a titration unit or component configured to analyze aseries of apneas and responses to stimulation until optimal settings areobtained for respiration detection and/or stimulation. The titrationunit or function may be a separate component of the apparatus 100, ormay be integral to one or more other components of the apparatus 100.

Once optimal settings are identified, the settings may be stored andutilized during subsequent operation of the apparatus 100. In contrast,when respiration detection parameters are identified as beinginsufficient, and/or when effectiveness of the stimulation is identifiedas suboptimal, one or more algorithms may be initiated to optimize theparameters thereof to improve the effectiveness of treatment for theparticular user. Such analysis may be performed periodically atpredetermined time intervals or less regularly. For patients with morecomplex or severe sleep apnea, more frequent analyses might berecommended. These analyses may also be stored in memory of theapparatus 100 for subsequent evaluation by a medical professional.

In an exemplary embodiment, the signal applied by the stimulator 140 maybe or comprise one or a sine wave, a saw-tooth wave, a square wave,and/or combinations thereof, among others. The signal may have one ormore frequencies each ranging between about 250 Hz and about 8000 Hz.The signal may range between about 25 dB and about 115 dB. The signalmay be a single tone, wave or other signal, or may comprise a series ofsuch signals, each having a duration ranging between about 0.05 secondsand about 1.0 seconds. Moreover, the restoration of the user's normalbreathing without waking the user may be accomplished with only acousticstimulation, such that other forms of stimulation (e.g., those includingor inducing muscle movement) are not necessary to restore normalbreathing.

FIG. 2 is a circuit diagram 250 of an exemplary embodiment of theapparatus 100 shown in FIG. 1 in accordance with one or more aspects ofthe present disclosure. Although the circuit diagram 250 is an exemplaryimplementation of the apparatus 100 shown in FIG. 1, otherimplementations are also within the scope of the present disclosure.

In the exemplary embodiment shown, the detector 105 includes athermistor 255 arranged in a bridge circuit having variable resistor 18and constant resistors R1, R2, and R3. During a breathing cycle of theuser, air-flow impinging on the thermistor 255 changes its resistanceand thus unbalances the bridge. Thereafter, current flowing throughresistors R4 and R5 will be amplified by the amplifier 110, and anoscillatory signal corresponding to the breathing cycle will be sentfrom the amplifier 110 via an output terminal 1. However, otherembodiments within the scope of the present disclosure may utilizealternative or additional detection mechanisms.

The oscillatory signal corresponding to the breathing cycle is passedvia capacitor C1 to the wave shaping circuit 115 consisting of the unitU1, resistor R8, and variable resistor R9. The shaped waveform at theoutput of the unit U1 is thus applied to terminal 11 of a counter U3.Each incoming pulse resets the counter U3. Simultaneously, the controlcircuit 130, including the unit U2/1 and the potentiometer R10,generates pulses or signals relating to the preset period of time, whilethe control circuit 130 applies the pulses via resistor R11 to the clockterminal 10 of the counter U3. The latter counts the number of pulseswhich are applied. If, within a period of time set by the resistor R9 ofthe shaping circuit 115, a reset pulse is not applied to the pause unit120, there appears on its output terminal 3 an output signal. The outputsignal is applied via lead 20 to the signal generator 135 which includesthe unit U2/3, the resistor R13, the power transistor T2, and thepotentiometer R14. The generator 135 forms a signal which is applied viaresistor R13 to the base of the transistor T2.

The transistor T2 conducts and activates the stimulator 140 as discussedherein. As long as a signal appears on terminal 3 of U3, the diode D1prevents the arrival of stimuli from the control circuit 130 to theterminal 10 of U3. This state of the unit U3 will prevail until a resetsignal initiated by the restoration of breathing arrives at terminal 11of the unit. The visual and/or acoustic monitor 125 receives activatingsignals from terminal 15 of the unit U3. These signals are passed viaunit U2/2, transistor T1, and resistor R12 to the light emitting-device(LED) L1. The LED L1 may be set to flicker during a normal breathingoperation.

FIG. 3 is a perspective view of a nasal-ear apparatus 150 disposed on auser 165 in accordance with one or more aspects of the presentdisclosure. The operation of the apparatus 150 may be substantiallysimilar or identical to that of the apparatus 100 shown in FIG. 1, andmay have a circuit diagram similar in function to the circuit 250 shownin FIG. 2. One or more aspects of the apparatus 150 and/or itscomponents may otherwise be substantially similar to those of theapparatus described above, with the possible exceptions described below.Nonetheless, it should be understood by those skilled in the art thatthe apparatus 150 shown in FIG. 3 is merely one example of the possibleimplementation of the apparatus 100 of FIG. 1, the circuit 250 of FIG.2, and/or other apparatus within the scope of the present disclosure.

The apparatus 150 is an exemplary embodiment of the apparatus 100, andis implemented as a goggle-, glasses- or mask-like device, wherein adetector is positioned in a portion of the apparatus 150 that iswearable around the nose, and another portion of the apparatus 150 fitswithin or around the ear for providing the above-described stimulation.The electronic components are positioned, for example, within the bodyof the goggle or externally, and this may utilize wireline or wirelesscommunication. Thus, the apparatus 150 may be configured to fit on anear 160 of the user 165 in a manner similar to a pair of glasses whichmay have one or two arms.

The detector 105 of the apparatus 150 is disposed proximate a nose 205of the user 165, for example. In the exemplary embodiment shown in FIG.3, the detector 105 is configured to measure the air-flow through thenose 205 of the user 165 and provide an electrical output signalindicative of the respiratory cycle of the user 165. Subsequently, thedetector 105 sends an electrical output signal to a control component orfunction via wireless means (e.g., radio frequency) or wireline means(e.g., a cable). The control function may be performed by a device orcomponent separate from the glasses. However, as depicted in FIG. 3, thecontrol component and/or control function is located within the glasses,such as in one or both arms of the glasses. For example, the controller102 of FIG. 1 may be housed within the body or arms of the glasses-likeapparatus 150 or, alternatively, may be housed external to the apparatus150 and configured to communicate with the apparatus 150 via wireless orwireline means.

One or more portions of the apparatus 150, or the entire apparatus 150,may be or comprise materials that are disposable. For example, theportion of the apparatus 150 that is positioned within or otherwiseproximate the nose 205 of the user 165 may be a disposable component ofthe apparatus 150 that is detachable and, thus, replaceable.Alternatively, or additionally, the portion of the apparatus 150 that ispositioned within or otherwise proximate the ear 160 of the user 165 maybe a disposable component of the apparatus 150 that is detachable and,thus, replaceable.

FIG. 4 is a schematic view of the stimulator 140 of the apparatus 150disposed in the ear 160 of the user 165 as shown in FIG. 3. The ear 160includes an outer ear 210, an ear canal 215 coupled to the outer ear210, and a tympanic membrane 145 disposed near the medial end of the earcanal 215. An ossicular chain 180, located in the middle ear anddisposed on the medial side of the tympanic membrane 145, couples andamplifies vibrations from the tympanic membrane 145 to the inner ear,which has a spiral structure known as the cochlea 155. The cochlea 155converts the vibrations into nerve stimuli to the brain. The structureof the outer ear 210 provides a “funnel” to direct and amplify soundwaves into the ear canal 215. The apparatus 150 may “worn” by the usersuch that the portion of the apparatus 150 which includes the stimulator140 is positioned in or near the ear 160 of the user 165. Alternatively,in other exemplary embodiments, the stimulator 150 or portion of theapparatus 150 which includes the stimulator 150 may be implanted in theskin of the ear 160, or possibly attached to the lobe or other sectionof the ear in a manner similar to an earring.

The stimulator 140 receives signals in response to an apnea episodeand/or other respiration disturbance and then applies electrical,electromagnetic, and/or acoustic signals to the ear 160 of the user 165.Where the signals are acoustic, they may be as described above. Theelectrical, electromagnetic, and/or acoustic signals may impact thetympanic membrane 145 and/or portions of the middle and inner ear andvibrate the ossicular chain 180, specifically the malleus 185, the incus190, and the stapes 195. These three bones in the ossicular chain 180act as a set of levers that amplify the vibrations received by thetympanic membrane 145. The stapes 195 is coupled to the entrance of thecochlea 155, which contains an inner ear fluid. The mechanicalvibrations of stapes 195 cause the fluid to develop fluid stimuli thatcauses small hair-like cells (not shown) in the cochlea 155 to vibrate.The vibrations are transformed into electrical stimuli which aretransmitted via neuro-pathways to the hearing center and other areas ofthe brain, and thereby stimulate the user 165. This stimulation, orother cortical responses, causes respiratory responses in the user 165,which results in the restoration of normal breathing for the user.Moreover, the restoration of normal breathing may be accomplishedwithout fully arousing the patient.

FIG. 5 is a schematic view of another embodiment of an apparatus 500configured to be positioned within the user's ear 160 according to oneor more aspects of the present disclosure. The operation of theapparatus 500 may be substantially similar or identical to that of theapparatus 100 shown in FIG. 1, and may have a circuit diagram similar infunction to the circuit 250 shown in FIG. 2. One or more aspects of theapparatus 500 and/or its components may otherwise be substantiallysimilar to those of the apparatus described above, with the possibleexceptions described below. The apparatus 500 is an exemplary embodimentof the apparatus 100, and is implemented as an ear bud or ear piececonfigured to be wholly enclosed within a housing 505 that is positionedor implanted in or near the ear 160 of the user 165. Nonetheless, itshould be understood by those skilled in the art that the apparatus 500shown in FIG. 5 is merely one example of the possible implementation ofthe apparatus 100 of FIG. 1, the circuit 250 of FIG. 2, and/or otherapparatus within the scope of the present disclosure.

FIG. 6 is a schematic view of the apparatus 500 shown in FIG. 5, with aportion of its outer housing 505 removed for clarity. The housing 505may be substantially cylindrical or otherwise configured to be receivedand retained within the user's ear 160, and houses at least a portion ofeach of a detector 510, a control unit 520, a stimulator 530, and wiresor other communicative means 540 interconnecting the control unit 520with the detector 510 and the stimulator 530. One or more aspects of thedetector 510, the control unit 520 and/or the stimulator 530 may besubstantially similar or identical to those described above. Forexample, the control unit 520 may be substantially similar or identicalin function and/or operation to the control device 102 shown in FIG. 1,and/or portions of the circuit 250 shown in FIG. 2.

The detector 510 is configured to detect the user's respiratory cycle,as in the embodiments described above. For example, the detector 510 maybe configured to detect the audible sounds of the user's respiratorycycle, such as where the detector 510 is or comprises a microphone orother sound-detecting device. Alternatively, or additionally, thedetector 510 may be configured to detect inaudible vibrations of theuser's respiratory cycle, such as those which may be transmitted to theuser's ear canal 215 through other portions of the user's ear and otherbody parts.

The stimulator 530 may be or comprise a speaker or othervibration-producing component configured to direct an audible orinaudible acoustic signal towards the user's tympanic membrane 145. Thecontrol unit 520 is configured utilize information received from thedetector 510 to determine when the user is experiencing a sleep apnea,as described above. In response to such determination, the control unit520 is further configured to direct the stimulator 530 to apply astimuli to the user's tympanic membrane 145 and/or portions of themiddle and/or inner ear, such as to vibrate the ossicular chain 180 and,ultimately, acoustically stimulate the user 165. This acousticstimulation, or other cortical responses, causes respiratory responsesin the user 165, which results in the restoration of normal breathingfor the user. Moreover, such results may restore normal breathingwithout waking or otherwise interrupting or disturbing the sleep cycleof the user.

It should be evident to those skilled in the pertinent art that thepresent disclosure introduces an automated respiration stimulationapparatus comprising, at least in one exemplary embodiment, a detectorconfigured to measure a respiratory cycle of a user and a stimulatorconfigured to automatically apply a stimulation to the user's acousticnerve to interrupt an abnormality, error, malfunction or otherdisturbance in the respiratory cycle of the user in response to thedetection of the disturbance as indicated by the respiratory cyclemeasurements of the detector. The stimulator may be configured toautomatically apply the stimulation to the user to interrupt thedisturbance in the respiratory cycle of the user and restore respirationwithout causing a full arousal of the user. The apparatus may furthercomprise a control device configured to receive and analyze an outputsignal from the detector to detect the disturbance in the respiratorycycle of the user and cause the stimulator to automatically apply thestimulation to the user in response to detection of the disturbance. Theapparatus may further comprise a pause unit configured to receive asignal from a wave shaping circuit. The detector may comprise at leastone of a thermistor configured to be positioned proximate the user'snose, a belt configured to be positioned proximate the user'sthoracoabdomen, a sensing element configured to be positioned in orproximate the user's ear, and a sensor configured to measure a bloodparameter of respiration. The apparatus may further comprise a housingconfigured to be at least partially received within the user's ear andcontaining at least a portion of at least one of the detector and thestimulator. The apparatus may be configured to be completely receivedwithin the user's ear. At least a portion of at least one of thedetector and the stimulator may be configured to be implanted into orattached to the user's ear. The detector and the stimulator may beintegrated into a structure configured to be worn over the user's ear.The detector may be configured to be positioned proximate the user'snose or inserted into the user's nose. The stimulation may compriseacoustic stimulation. At least one operational parameter of thestimulator may be configured to be adjusted, wherein the at least oneoperational parameter may be selected from the group consisting of:signal frequency, signal spacing, signal duration, signal shape, signalvolume and number of signals. At least one operational parameter of thestimulator may be configured to be adjusted based upon characteristicsof the user in an automatic or manual manner. At least one operationalparameter of the stimulator may be configured to change over time. Thestimulator may be configured to continue to periodically apply thestimulation to the user's acoustic nerve until detection of a normalrespiratory cycle by the detector. The stimulator may be configured toapply successive and progressive stimulation until detection of a normalrespiratory cycle by the detector. The apparatus may further comprise anintegrated circuit comprising at least a portion of each of the detectorand the stimulator.

The present disclosure also introduces a method of stimulatingrespiration in a user, wherein at least one exemplary embodimentcomprises detecting a respiratory cycle of the user, and acousticallystimulating the user's acoustic nerve automatically upon detection of anerror in the respiratory cycle of the user. The method may furthercomprise adjusting the acoustic stimulation in response to therespiratory cycle of the user. The step of acoustically stimulating theuser may not fully arouse the user but may still restore the user'snormal respiration cycle, thereby interrupting a sleep apnea episode ofthe user without fully waking the user.

The foregoing outlines features of several embodiments so that thoseskilled in the art may better understand the aspects of the presentdisclosure. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure.

1. An automated respiration stimulation apparatus, comprising: adetector configured to measure a respiratory cycle of a user; and astimulator configured to automatically apply a stimulation to the user'sacoustic nerve to interrupt a disturbance in the respiratory cycle ofthe user in response to the detection of the disturbance as indicated bythe respiratory cycle measurements of the detector.
 2. The apparatus ofclaim 1 wherein the stimulator is configured to automatically apply thestimulation to the user to interrupt the disturbance in the respiratorycycle of the user without causing a full arousal of the user.
 3. Theapparatus of claim 1 further comprising a control device configured toreceive and analyze an output signal from the detector to detect thedisturbance in the respiratory cycle of the user and cause thestimulator to automatically apply the stimulation to the user inresponse to detection of the disturbance.
 4. The apparatus of claim 3further comprising a pause unit configured to receive a signal from awave shaping circuit.
 5. The apparatus of claim 1 wherein the detectorcomprises at least one of a thermistor configured to be positionedproximate the user's nose, a belt configured to be positioned proximatethe user's thoracoabdomen, a sensing element configured to be positionedin or proximate the user's ear, and a sensor configured to measure ablood parameter of respiration.
 6. The apparatus of claim 1 furthercomprising a housing configured to be at least partially received withinthe user's ear and containing at least a portion of at least one of thedetector and the stimulator.
 7. The apparatus of claim 1 wherein theapparatus is configured to be completely received within the user's ear.8. The apparatus of claim 1 wherein at least a portion of at least oneof the detector and the stimulator is configured to be implanted into orattached to the user's ear.
 9. The apparatus of claim 1 wherein thedetector and the stimulator are integrated into a structure configuredto be worn over the user's ear.
 10. The apparatus of claim 1 wherein thedetector is configured to be positioned proximate the user's nose orinserted into the user's nose.
 11. The apparatus of claim 1 wherein thestimulation comprises acoustic stimulation.
 12. The apparatus of claim 1wherein at least one operational parameter of the stimulator isconfigured to be adjusted, wherein the at least one operationalparameter is selected from the group consisting of: signal frequency,signal spacing, signal duration, signal shape, signal volume and numberof signals.
 13. The apparatus of claim 12 wherein the at least oneoperational parameter of the stimulator is configured to be adjustedbased upon characteristics of the user in an automatic or manual manner.14. The apparatus of claim 12 wherein the at least one operationalparameter of the stimulator is configured to change over time.
 15. Theapparatus of claim 1 wherein the stimulator is configured to continue toperiodically apply the stimulation to the user's acoustic nerve untildetection of a normal respiratory cycle by the detector.
 16. Theapparatus of claim 1 wherein the stimulator is configured to applysuccessive and progressive stimulation until detection of a normalrespiratory cycle by the detector.
 17. The apparatus of claim 1 furthercomprising an integrated circuit comprising at least a portion of eachof the detector and the stimulator.
 18. A method of stimulatingrespiration in a user, comprising: detecting a respiratory cycle of theuser; and acoustically stimulating the user's acoustic nerveautomatically upon detection of a disturbance in the respiratory cycleof the user.
 19. The method of claim 18 further comprising adjusting theacoustic stimulation in response to the respiratory cycle of the user.20. The method of claim 18 wherein the step of acoustically stimulatingthe user's acoustic nerve does not fully arouse the user but doesrestore the user's normal respiration cycle, thereby interrupting thedisturbance in the respiratory cycle of the user without fully wakingthe user.